On October 29, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported dosing of the first patient in China in the global POD1UM-101 study evaluating retifanlimab in patients with previously treated, microsatellite instability-high endometrial cancer (Press release, Zai Laboratory, OCT 29, 2020, View Source [SID1234569580]).
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"Endometrial cancer is one of the most common gynecological cancers in China and represents a significant unmet need," said Dr. Beihua Kong, Professor of Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University. "More specifically, high levels of microsatellite instability (MSI-H) have been reported in up to 30% of all endometrial cancers in the recurrent setting. PD-1 inhibition with a therapeutic such as retifanlimab represents a promising clinical approach for these patients."
This is a potentially registrational, Phase 1b, open-label study evaluating retifanlimab as monotherapy in patients with previously treated, MSI-H endometrial cancer. The study is expected to enroll approximately 100 patients in the US and China. The primary endpoint of the study is overall response rate (ORR). Key secondary endpoints include duration of response (DOR), progression free survival (PFS), overall survival (OS), safety and pharmacokinetics.
About Endometrial Cancer
Endometrial cancer is one of the most common gynecological cancers in China, and its incidence is increasing. Surgery is the main treatment for most women with this cancer, with 5-year overall survival (OS) rate of 81.2%. However, the 5-year OS rate is only 17.3% for patients with metastasis or recurrence, and effective treatment options are limited.
About Retifanlimab
Retifanlimab (formerly INCMGA0012), an investigational anti-PD1 antibody, is currently under evaluation in registration-directed studies as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.
In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and exclusive commercialization of retifanlimab in China, Hong Kong, Macau and Taiwan.